A decellularized matrix of a tissue and organ has been used for human tissue restoration, various tissue engineering studies and regenerative medicine researches. There are great similarity and homology in the extracellular matrices of tissues and organs of human bodies and many animals. A biological matrix material manufactured by decellularizing an allogeneic or xenogenic tissue and organ has been successfully used for repair and restoration of human tissues in clinical medicine. After a good matrix of a tissue and organ is implanted into the host, the matrix scaffold material provides an initial biomechanical support and regulates cell behavior (e.g., adherence, migration, proliferation and differentiation) by interacting with a host cell, and the matrix of the tissue and organ itself is gradually converted into a new tissue with ingrowth of the host cells.
After removal of original cell components of a tissue and organ of an animal, the matrix of the tissue and organ having a three-dimensional scaffold structure can also be re-cellularized and functionalized by incorporating human cells in vitro, thereby finally producing a tissue and organ which can be implanted into the human body.
A matrix of a tissue and organ is a three-dimensional scaffold composed of various complex structural proteins and functional proteins, and comprises many other active complexes. Main components include collagenous fiber, glycoprotein, mucoprotein, and the like, and other components include saccharides such as glycosaminoglycan (hyaluronic acid, chondroitin sulfate), some lipids and growth factors. A process procedure for manufacturing the matrix of the tissue and organ is very complex, including processes such as collection, preservation, washing, disinfection, decellularization, antigenicity reduction, virus inactivation and terminal sterilization of the tissue and organ, and the like. Among these processes, the disinfection and sterilization treatment of the animal tissue causes great damage on the matrix of the tissue and organ, which severely changes biochemical constituents of the matrix of the tissue and organ while inactivating bacteria and viruses, thereby disrupting the three-dimensional ultrastructures and altering biomechanical properties. These changes influence the response of the host to the implanted matrix material, and possibly result in the less desirable clinical outcomes of the product of the tissue matrix, and thus making it difficult to achieve proper human tissue repair.
The method for disinfection, sterilization and virus inactivation of the material of the animal tissue is used throughout each process step of the manufacture process for the scaffold of the tissue matrix. Currently, applicable methods mainly relate to several methods as follows. The first one is a physical method, which decreases the number of bacteria and fungi by flushing and diluting, and operates under a sterile environment to prevent a re-infection; the second one is to add a microbial growth inhibitor and an antibiotic in a preparation solution; the third one is to incorporate a special sterilization step into the preparation process procedure, so as to control the number of bacteria; and the fourth one is terminal sterilization treatment of the product. The sterilization method in the preparation process procedure is to treat with a chemical oxidant (peracetic acid, sodium hypochlorite, hydrogen peroxide or iodine solution, or the like), alcohol, or acid or base (acetic acid, hydrochloric acid, sodium hydroxide). The test results indicate that these commonly used methods for disinfection and sterilization treatment have different degrees of damage on the tissue matrix. One of the issues required to be further studied in the field of tissue engineering science and biological material science is how to disinfect, sterilize, and inactivate viruses more effectively, without damaging the original basic structure of the extracellular tissue matrix, and changing the main biochemical constituents and biomechanical properties.